Agency classClass IIOur severity:High FDA (Devices)·Z-1647-2022·Announced 2022-09-07

Siemens Artis icono X-Ray Systems Recalled for Potential Hardware Failure

Siemens has recalled Artis icono X-ray imaging systems due to a potential hardware issue affecting a specific lot of X-ray tubes. If the error detection mechanism fails, the system cannot release X-rays until it is shut down.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is a potential hardware failure that could prevent device operation but has not resulted in reported patient harm. Per the rubric, recalls with theoretical risk where injury has not been reported are classified as High.

Plain-English summary

Siemens Medical Solutions USA, Inc. has issued a recall for certain serial numbers of the Artis icono biplane (Model No. 11327600) and Artis icono floor (Model No. 11327700) X-ray imaging systems. These systems are affected by a potential hardware issue involving a specific lot of X-ray tubes.

The issue involves the error detection mechanism. In rare cases, if this mechanism fails, the system will not be able to release X-rays until it is shut down and restarted. This could interrupt diagnostic imaging operations.

A total of 1,389 units are affected, including 590 in the United States and 799 outside the United States. These systems have been distributed worldwide to medical facilities.

Healthcare facilities with affected Artis icono systems should verify their device serial numbers against the FDA recall notice and contact Siemens Medical Solutions for guidance and any available corrections or updates.

The recalled product

Product: Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Imaging Equipment
Hazard: device-malfunction
error-detection-failure

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →

Moderate
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Same hazard · device malfunction